NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02
Drug Recall
Official source record
- Recall number
- D-0002-2019
- Event ID
- 81011
- Classification
- Class II
- Status
- Terminated
- Recalling company
- BioLyte Laboratories, LLC
- Reason for recall
- CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
- Report date
- October 10, 2018
- Recall initiation date
- August 31, 2018
- Termination date
- August 31, 2020
- Distribution pattern
- Nationwide in the USA
Drug product identifiers
- Manufacturer
- BioLyte Laboratories, LLC
- Brand name
- NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS
- Generic name
- TOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESS
- Substance names
- ARNICA MONTANA; ARTEMISIA CINA PRE-FLOWERING TOP; ATROPA BELLADONNA ROOT; BLACK COHOSH; CAUSTICUM; FRANGULA CALIFORNICA BARK; HYPERICUM PERFORATUM; JATROPHA CURCAS SEED; LYCOPODIUM CLAVATUM SPORE; POTASSIUM BROMIDE; POTASSIUM CARBONATE; PSEUDOGNAPHALIUM OBTUSIFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; SCUTELLARIA LATERIFLORA; STRYCHNOS IGNATII SEED; TARAXACUM OFFICINALE; VALERIAN; VERATRUM ALBUM ROOT
- Product NDC
- 58368-002
- Package NDC
- 58368-002-02
- Route
- TOPICAL
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
